75 0 95 5 19 MAY 26 1981
32 4 63 12 ADDENDUM I DAWSON RESEARCH CORPORATION Protocol Change Order No. 1
73 15 81 16 5-13-81
68 15 73 16 Date
13 16 29 17 Protocol LRC-5A
21 19 84 21 Change in the time of the Pre- dose Biomicroscopic Examination
13 20 20 21 Subject
58 27 66 29 5-13-81
75 27 88 29 Verbal Phone
52 27 57 29 Date
13 28 27 29 Authorized by
28 28 45 29 Dr. Connie Stone
68 28 75 29 Method
68 29 94 31 (Means of communication)
28 32 46 34 Mr. Charles Burns
13 33 27 34 Authorized to
13 35 51 37 Estimated cost of the study will be:
35 39 37 40 ☑
62 39 72 40 decreased
81 39 94 40 not affected
40 39 51 40 increased
13 42 42 44 Description of change order:
13 45 90 49 Section III A. 2nd paragraph- the first sentence is to be changed to read as follows:
18 50 90 55 Twenty-four to 30 hours prior to dosing, both eyes of each rabbit will be examined by an experienced investigator using a slit lamp biomicroscope.
13 56 90 61 The change was made so the protocol more closely conforms with the proposed regulations as stated in the Federal Register, Vol. 44, No. 145, 772.112-24 Primary Eye Irritation Study.
80 69 82 78 00851879
57 84 97 92 
15 84 52 92 
19 92 38 94 Sponsor Signature
64 92 79 94 Study Director Signature
